BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM

    MDR report key: 11867776 · Received May 21, 2021

    Report

    Report Number
    2243471-2021-01432
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 22, 2021
    Report Date
    August 6, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    2243471-03-17-2021-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S COBAS LIAT ANALYZER (S/N (B)(6) WAS RETURNED FOR EVALUATION AND REPAIR. FROM THE INSPECTION, IT WAS IDENTIFIED THAT THERE WAS ONE THERMAL RUNAWAY EVENT SEEN WHICH OCCURRED DURING RUN #1238 (22.APR.2021) WHICH PROVOKED THE SHUTDOWN OF THE HEATING MODULE. ALL FOLLOWING RUNS SHOWED A POTENTIALS FALSE POSITIVE FOR COVID DUE TO THE REOCCURRING THERMAL SHUTDOWN REMAINED UNDETECTED BY THE SYSTEM SOFTWARE. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS LIAT SYSTEM, PRODUCT CODE: OCC CATALOG NUMBER 07341920190 AND UDI (B)(4). THE TEST USED ON THE COBAS LIAT SYSTEM IS THE COBAS SARS-COV-2 & INFLUENZA A/B TEST PRODUCT CODE QJR, CATALOG NUMBER 09211101190 AND UDI. (B)(4). (B)(4).

    Additional Manufacturer Narrative · 0

    ROCHE RECEIVED COMPLAINTS ALLEGING INVALID AND/OR FALSE POSITIVE RESULTS WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS® LIAT® SYSTEM FOR ONE OR MORE TARGETS (SARS-COV-2, INFLUENZA A, INFLUENZA B). WHEN REVIEWING THE CUSTOMER-PROVIDED DATA ASSOCIATED WITH THE REPORTED INVALID AND FALSE POSITIVE RESULTS, ABNORMAL PCR CURVES WERE OBSERVED. PER THE ON-GOING INVESTIGATION, SEVERAL POTENTIAL CAUSES FOR THE ABNORMAL PCR GROWTH CURVES LEADING TO INVALIDS AND FALSE POSITIVES HAVE BEEN IDENTIFIED. THESE INCLUDE TUBE LEAKS, ABNORMAL PCR STEPS, AND LOOSE THERMAL SENSOR WIRING. OVERALL ACROSS THE INSTALLED BASE, THESE ISSUES FROM PRODUCT USE MAY OCCUR SPORADICALLY. FOR INVALID OR FALSE POSITIVE INFLUENZA RESULTS, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY. FOR INVALID SARS-COV-2, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY SINCE DETECTABILITY IS HIGH AND TESTING CAN BE PERFORMED ON ALTERNATIVE PLATFORMS. FOR ERRONEOUS POSITIVE SARS-COV-2 RESULTS, THERE IS THE POSSIBILITY OF ADVERSE HEALTH CONSEQUENCES IN HIGH RISK INDIVIDUALS. AS STATED IN THE INSTRUCTIONS FOR USE, CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. A COBAS LIAT SOFTWARE UPDATE AND A NEW COBAS® SARS-COV-2 & INFLUENZA A/B SCRIPT TO BETTER IDENTIFY ERRORS AND DETECT ABNORMAL PCR CURVES WILL BE MADE AVAILABLE BETWEEN APRIL - JUNE 2021. CONSIGNEES HAVE BEEN NOTIFIED. (B)(4)

    Description of Event or Problem · 0

    IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT EMERGENCY USE AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTIC TESTS, THE AGENCY HAS REQUESTED HEIGHTENED REPORTING BEYOND THE REASONABLY SUGGESTS REQUIREMENTS OF 803 TO INCLUDE ALLEGATIONS OF FALSE POSITIVE OR FALSE NEGATIVE RESULTS INDEPENDENT OF HARM OR MALFUNCTION OR OFF-LABEL USE. PURSUANT TO THE AGENCY¿S INSTRUCTION, WE HEREBY SUBMIT THIS MDR. THE CUSTOMER ALLEGED DISCREPANT RESULTS GENERATED FOR COBAS® SARS-COV-2/INFLUENZA A/B ASSAY. A CUSTOMER FROM THE UNITED STATES ALLEGED THAT POTENTIAL FALSE POSITIVE RESULTS WERE OBSERVED FOR THE COBAS® SARS-COV-2/INFLUENZA A/B ANALYZED ON THE COBAS LIAT SYSTEM (S/N (B)(4)). THE CUSTOMER REPORTED THAT THEY OBSERVED DISCREPANT RESULTS GENERATED FROM THE COBAS LIAT SYSTEM (S/N (B)(4)) FOR THREE PATIENT SAMPLES. THE ORIGINAL SAMPLE FOR PATIENT 1 WAS RUN AND ANALYZED ON THE COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV2 POSITIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULT. PATIENT 1¿S SAME SAMPLE WAS RERUN AND ANALYZED ON COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV2 NEGATIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULT. THE SAME SAMPLE FOR PATIENT 1 WAS RERUN A SECOND TIME ON COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV2 NEGATIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULT. THE SECOND PATIENT¿S ORIGINAL SAMPLE WAS RUN AND ANALYZED ON THE COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV2 POSITIVE, INFLUENZA A INVALID AND INFLUENZA B NEGATIVE RESULT. THE SAME SAMPLE FOR PATIENT 2 WAS RERUN AND ANALYZED ON COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV2 NEGATIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULT. THE THIRD PATIENT¿S ORIGINAL SAMPLE WAS RUN AND ANALYZED ON THE COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV2 POSITIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULT. PATIENT 3¿S SAME SAMPLE WAS RERUN AND ANALYZED ON COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV2 NEGATIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULT. THE SAME SAMPLE FOR PATIENT 3 WAS RERUN A SECOND TIME ON COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV2 NEGATIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULT. TWO ADDITIONAL SAMPLES WERE IDENTIFLED A GENERATING DISCREPANT RESULTS; HOWEVER, NO DATA WAS PROVIDED. PATIENTS¿ SAMPLE WERE COLLECTED USING NASAL SWAB AND MICROTEST REMEL M4RT NO BEADS. THIS IS NOT A RECOMMENDED PRACTICE FOR SAMPLE COLLECTION. AS PER THE METHOD SHEET, COLLECT SPECIMEN USING A STERILE FLOCKED SWAB WITH A SYNTHETIC TIP ACCORDING TO APPLICABLE MANUFACTURER INSTRUCTIONS AND/OR STANDARD COLLECTION TECHNIQUE USING 3 ML OF VIRAL TRANSPORT MEDIA OR STERILE 0.9% PHYSIOLOGICAL SALINE. THE CUSTOMER CONFIRMED THERE WAS NO ALLEGATION OF HARM TO THE PATIENTS. THE RESULTS POSITIVE AND NEGATIVE WERE REPORTED OUT TO THE PATIENT AND/OR PERSONNEL TREATING PATIENT 1, NEGATIVE RESULTS WERE REPORTED OUT TO THE PATIENT AND/OR PERSONNEL TREATING PATIENT 2 AND DOCTOR AND PATIENT WERE GIVEN NEGATIVE RESULTS FOR PATIENT 3. THE INVESTIGATION TO ASSESS THE CUSTOMER ALLEGATION HAS NOT YET BEEN COMPLETED. FIVE (5) MDRS WILL BE FILED ONE FOR EACH SAMPLE AS PER FDA GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762887 COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 01221Y

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR